Strategic Supplier Quality Engineer II – Medical Devices

INTEGRA LIFESCIENCES PRODUCTION CORPORATION; Mansfield (MA); On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life insurance

Disability Insurance

401(k)

Job summary

Integra LifeSciences is seeking a Supplier Quality Engineer II to lead supplier QA activities at contract manufacturers and raw material suppliers, ensuring compliance with FDA 21 CFR Part 820 and ISO 13485. This role focuses on audits, CAPA, supplier quality agreements, and change control.

You will collaborate with QC, Manufacturing, and Purchasing to improve supplier performance and support business continuity in a regulated environment, based in Mansfield, MA.

Qualifications

• Bachelor’s degree in Engineering, Life Science, or related technical discipline.
• Minimum 3 years of professional work experience in GMP/ISO regulated industry.
• Knowledge of ISO13485, 93/42/EEC, 21 CFR part 820.
• Strong communication, teamwork, and organizational skills.
• Strong analytical problem solving and root cause analysis skills.
• Experience with ERP/PLM systems and MS Office.
• Knowledge of statistical techniques.

Responsibilities

• Lead quality assurance for contract manufacturers and suppliers.
• Maintain Approved Supplier List and audit schedules.
• Conduct supplier audits per GMP/ISO and regulatory requirements.
• Manage Supplier Quality Agreements and supplier change control.
• Provide QA support to QC, purchasing, and production.
• Support CAPA, investigations, and validation efforts for outsourced processes.
• Escalate supplier quality issues and drive compliant solutions.

Skills

Quality assurance

Regulatory compliance

Root cause analysis

ERP systems

PLM systems

Microsoft Office

Statistical techniques

Education

Bachelor's degree in Engineering or Life Science

Tools

ERP

PLM

Microsoft Office

Job description

Integra LifeSciences is seeking a Supplier Quality Engineer II to lead supplier QA activities at contract manufacturers and raw material suppliers, ensuring compliance with FDA 21 CFR Part 820 and ISO 13485. This role focuses on audits, CAPA, supplier quality agreements, and change control.

You will collaborate with QC, Manufacturing, and Purchasing to improve supplier performance and support business continuity in a regulated environment, based in Mansfield, MA.